On September 6, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported that Chief Financial Officer Kirk Look will participate in a fireside chat at the H.C. Wainwright 26th Annual Global Investment Conference, which is taking place September 9-11, 2024 at the Lotte New York Palace Hotel in New York, NY (Press release, Oncolytics Biotech, SEP 6, 2024, View Source [SID1234646394]). Chief Medical Officer Tom Heineman, M.D., Ph.D., will participate in a fireside chat at the 2024 Cantor Global Healthcare Conference, which is taking place September 17-19, 2024 at the InterContinental New York Barclay Hotel in New York, NY. Additional details on the fireside chats can be found below.

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Event: H.C. Wainwright 26th Annual Global Investment Conference
Date: Wednesday, September 11, 2024
Time: 9:00 a.m. ET
Location: Lotte New York Palace Hotel, Holmes I Room – 4th Floor
Webcast Link: Available by clicking here

Event: Cantor 2024 Global Healthcare Conference
Date: Thursday, September 19, 2024
Time: 10:55 a.m. ET
Location: InterContinental New York Barclay Hotel, Track 6 Morgan Suite
Webcast Link: Available by clicking here

Company management will also be participating in one-on-one investor meetings at the conferences. To schedule a meeting, please submit a request on the conference website, contact your H.C. Wainwright or Cantor Fitzgerald representative, or email [email protected].

Webcasts of the Company’s presentations will also be available on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months.

On September 6, 2024 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and other serious diseases, reported that management will host a webcast and conference call at 8:00 a.m. ET (5:00 a.m. PT) on Monday, September 9, 2024 to introduce new XmAb programs in development for the treatment of patients with autoimmune diseases and to provide updates on continued progress in dose escalation with first-in-class oncology programs, including XmAb819 (ENPP3 x CD3) in patients with advanced clear cell renal cell carcinoma and XmAb808 (B7-H3 x CD28) in patients with advanced solid tumors (Press release, Xencor, SEP 6, 2024, View Source [SID1234646395]).

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The live webcast may be accessed through "Events & Presentations" in the Investors section of the Company’s website, located at investors.xencor.com. Telephone participants may register to receive a dial-in number and unique passcode that can be used to access the conference call. A recording will be available for at least 30 days.

On September 5, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its lead program MDG1015 for the treatment of advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma in the phase 1 clinical trial (EPITOME1015-I) (Press release, MediGene, SEP 5, 2024, View Source [SID1234646380]).

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EPITOME1015-I consists of a dose escalation followed by an expansion segment and aims to assess safety, feasibility and preliminary efficacy of MDG1015 in multiple solid tumor indications.

"We are very excited to reach this milestone with our lead program MDG1015 which reinforces our ambition to become a leading company with a range of different TCR-guided therapies for patients suffering from multiple advanced solid tumor types," said Selwyn Ho, CEO of Medigene AG. "In preclinical studies, MDG1015 has shown strongly enhanced and persistent T cell-driven anti-tumor activity and the ability to mitigate the effects of PD-L1, one of the major immunosuppressive signals present in the tumor microenvironment of solid cancers which hinder the effectiveness of TCR-T therapies. This very first FDA clearance of an IND Application for a Medigene TCR-T therapy represents a pivotal achievement, and we look forward to commencing our MDG1015 phase 1 study EPITOME1015-I targeting multiple solid tumors, subject to additional financing."

MDG1015 is a first-in-class, third generation T cell receptor engineered T cell (TCR-T) therapy targeting the cancer-testis antigen New York esophageal squamous cell carcinoma 1 / L Antigen Family Member-1a (NY-ESO-1/LAGE-1a) with a natural and optimal affinity 3S (specific, sensitive and safe) TCR and human leukocyte antigen (HLA)-A*02. The TCR-T cells are further armored and enhanced by the addition of the proprietary PD1-41BB costimulatory switch protein (CSP) technology and has demonstrated significantly enhanced anti-tumor activities against tumor cells expressing varying levels of PD-L1, one of the most immunosuppressive signals emanating from the solid tumor microenvironment. Importantly, compared to first generation TCR-T therapies, MDG1015 will be manufactured with a short, 6-day cell expansion period, leading to younger, fitter cells, with the potential for a markedly reduced number of cells required during dosing and a shorter vein-to-vein time for patients of approximately 20 days. This has also resulted in a drug product with an almost pure CD8+ population and with a very high proportion of cells with stemness-like qualities (~95%) that could lead to improved durability of response, greater efficacy and reduced adverse events.

To complement the IND approval, a Clinical Trial Application (CTA) submission for MDG1015 to the European Medicines Agency (EMA) is on track for the fourth quarter of 2024. Pending additional financing, the Company plans to initiate the phase 1 clinical trial EPITOME‑1015-I, which consists of a dose escalation followed by an expansion segment, by the end of 2024. Based on this timeline, the Company expects to be able to present early data from the dose escalation phase towards the end of 2025.

On September 5, 2024 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that the company is scheduled to present at the 2024 Cantor Global Healthcare Conference on Wednesday, September 18, 2024, at 10:20 a.m. ET (Press release, Agios Pharmaceuticals, SEP 5, 2024, View Source [SID1234646365]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.

On September 5, 2024 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer and rare diseases, reported that new clinical data from an ongoing Phase 1 study of P-BCMA-ALLO1 in patients with relapsed/refractory multiple myeloma will be presented in an oral session at the 21st International Myeloma Society (IMS) Annual Meeting, which is being held in Rio de Janeiro from September 25-28, 2024 (Press release, Poseida Therapeutics, SEP 5, 2024, View Source [SID1234646381]). The Company is developing P-BCMA-ALLO1, an investigational off-the-shelf allogeneic CAR-T cell therapy enriched for stem cell memory T cells (TSCM), in partnership with Roche for the treatment of relapsed/refractory multiple myeloma.

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"Despite therapeutic advances, multiple myeloma remains an incurable hematologic cancer and relapses are common with BCMA-targeting immunotherapies, such as bispecific T-cell engagers and autologous CAR-T therapies. As a result, patient-focused, off-the-shelf therapies are needed that can provide clinical benefit to patients with relapsed or refractory disease," said Syed Rizvi, M.D., Chief Medical Officer of Poseida Therapeutics. "We look forward to presenting the latest data from our ongoing Phase 1 study of P-BCMA-ALLO1 and its potential as an ‘off-the-shelf’ therapy for patients at IMS. We are also pleased to announce the initiation of the Phase 1b portion of the study, which will allow us to further explore the promise of this program."

IMS Oral Presentation

Talk Title: OA – 04: A Phase 1 Study of P-BCMA-ALLO1, a Non-viral, Allogeneic BCMA Directed CAR-T in Relapsed/Refractory Multiple Myeloma (RRMM)
Presenting Author: Bhagirathbhai R. Dholaria, MBBS, Assistant Professor of Medicine, Department of Medicine, Division of Hematology and Oncology, Vanderbilt University Medical Center
Session: Abstract Session 7
Presentation Date/Time: Friday, September 27, 2024, at 5:42 PM-5:54 PM local time (4:42 PM ET / 1:42 PM PT)
Room: 101 A1-A2
Company-Hosted IMS Webcast and Conference Call Information:
Poseida will host a webcast and conference call on Saturday, September 28, 2024, at 1 PM ET / 10 AM PT. The conference call can be accessed by dialing 800-225-9448 or 203-518-9708 (International) with the conference ID PSTX0928. A live webcast may be accessed using the link here, or by visiting the Events and Presentations section of the Poseida website at investors.poseida.com. After the live webcast, the event will remain archived on the Poseida site for approximately 90 days.

P-BCMA-ALLO1 Phase 1b Clinical Trial
The Company also announced the initiation of a Phase 1b portion of the ongoing Phase 1 clinical trial of P-BCMA-ALLO1 in patients with multiple myeloma. As a result of achieving this milestone, Poseida will receive a $20 million payment from Roche. Poseida and Roche partnered together on the P-BCMA-ALLO1 Phase 1b trial design, which incorporates process improvements and feedback from recently completed advisory board meetings with leading clinicians. Poseida will continue to have responsibility for the expanded Phase 1/1b trial, which will be funded by Roche.

About P-BCMA-ALLO1
P-BCMA-ALLO1 is an allogeneic CAR-T product candidate licensed to Roche targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma. This allogeneic program includes a VH-based binder that targets BCMA and clinical data presented at ASH (Free ASH Whitepaper) in December 2023 support the Company’s belief that T stem cell (TSCM)-rich allogeneic CAR-Ts have the potential to offer effective, safe, and reliable treatment addressing unmet needs in multiple myeloma. Additional information about the Phase 1 study is available at www.clinicaltrials.gov using identifier: NCT04960579.